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ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Primary Purpose

Opiate Dependence

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

VIVITROL® 380 mg

Placebo

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Addiction, Opiate dependence, Inpatient detoxification, opioid dependence, heroin dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Primary Inclusion Criteria:

Written, informed consent
18 years of age or older
Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria
Voluntarily seeking treatment for opioid dependence
Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days
Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone
Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures
Agree to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

Pregnancy or lactation
Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings)
Positive naloxone challenge test at randomization (Day 0)
Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects
Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) >3xULN
Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study
Recent history (within 6 months prior to screening) of suicidal ideation or attempt
Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine
Active alcohol dependence within prior 6 months
Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study
Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening
Use of oral naltrexone for 7 consecutive days within 60 days prior to screening
Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)

Sites / Locations

Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIVITROL® 380 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)

Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.

Secondary Outcome Measures

Days to Discontinuation During Part A

Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.

Craving Score: Change From Baseline

Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving").

Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)

Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.

Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24

Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.

Full Information

NCT ID

NCT00678418

First Posted

May 14, 2008

Last Updated

December 21, 2016

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00678418

Brief Title

ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Official Title

Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence. The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Detailed Description

Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults. Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year. At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years. Dosing was performed by the principal investigator or designated study staff member. All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opiate Dependence

Keywords

Addiction, Opiate dependence, Inpatient detoxification, opioid dependence, heroin dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIVITROL® 380 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

VIVITROL® 380 mg

Other Intervention Name(s)

Naltrexone for extended-release injectable suspension, Medisorb® naltrexone

Intervention Description

Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Primary Outcome Measure Information:

Title

Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)

Description

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Days to Discontinuation During Part A

Description

Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.

Time Frame

168 days (24 weeks)

Title

Craving Score: Change From Baseline

Description

Time Frame

Baseline to 6 months (24 weeks)

Title

Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)

Description

Time Frame

24 Weeks

Title

Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24

Description

Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Primary Inclusion Criteria: Written, informed consent 18 years of age or older Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria Voluntarily seeking treatment for opioid dependence Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures Agree to use contraception for study duration if of childbearing potential Primary Exclusion Criteria: Pregnancy or lactation Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings) Positive naloxone challenge test at randomization (Day 0) Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) >3xULN Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study Recent history (within 6 months prior to screening) of suicidal ideation or attempt Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine Active alcohol dependence within prior 6 months Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening Use of oral naltrexone for 7 consecutive days within 60 days prior to screening Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)

Overall Study Officials: